Astramorph PF

Name: Astramorph PF

Uses For Astramorph PF

Morphine injection is used to relieve moderate to severe pain. It may also be used before or during surgery with an anesthetic (medicine that puts you to sleep). Morphine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

Contraindications

Astramorph/PF is contraindicated in those medical conditions which would preclude the administration of opioids by the intravenous routeallergy to morphine or other opiates, acute bronchial asthma, upper airway obstruction.

Astramorph/PF, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain blood pressure has already been compromised by a depleted blood volume or a concurrent administration of drugs, such as phenothiazines or general anesthetics (see also, PRECAUTIONS: Use with Other Central Nervous System Depressants).

Adverse reactions

The most serious adverse experience encountered during administration of Astramorph/PF is respiratory depression and/or respiratory arrest.  This depression and/or respiratory arrest may be severe and could require intervention (see  WARNINGS and OVERDOSAGE). Because of delay in maximum CNS effect with intravenously administered drug (30 min), rapid administration may result in overdosing. Single-dose neuraxial administration may result in acute or delayed respiratory depression for periods at least as long as 24 hours.

Tolerance and Myoclonus:

See  WARNINGSfor discussion of these and related hazards.

While low doses of intravenously administered morphine have little effect on cardiovascular stability, high doses are excitatory, resulting from sympathetic hyperactivity and increase in circulating catecholamines.  Excitation of the central nervous system, resulting in convulsions, may accompany high doses of morphine given intravenously. Dysphoric reactions may occur after any size dose and toxic psychoses have been reported.

Pruritus:

Single-dose epidural or intrathecal administration is accompanied by a high incidence of pruritus that is dose-related but not confined to the site of administration. Pruritus, following continuous infusion of epidural or intrathecal morphine, is occasionally reported in the literature; these reactions are poorly understood as to their cause.

Urinary retention:

Urinary retention, which may persist 10 to 20 hours following single epidural or intrathecal administration, is a frequent side effect and must be anticipated primarily in male patients, with a somewhat lower incidence in females.  Also frequently reported in the literature is the occurrence of urinary retention during the first several days of hospitalization for the initiation of continuous intrathecal or epidural morphine therapy. Patients who develop urinary retention have responded to cholinomimetic treatment and/or judicious use of catheters (see PRECAUTIONS).

Constipation:

Constipation is frequently encountered during continuous infusion of morphine; this can usually be managed by conventional therapy.

Headache:

Lumbar puncture-type headache is encountered in a significant minority of cases for several days following intrathecal catheter implantation; this, generally, responds to bed rest and/or other conventional therapy.

Other:

Other adverse experiences reported following morphine therapy includeDizziness, euphoria, anxiety, hypotension, confusion, reduced male potency, decreased libido in men and women, and menstrual irregularities including amenorrhea, depression of cough reflex, interference with thermal regulation and oliguria.  Evidence of histamine release such as urticaria, wheals and/or local tissue irritation may occur. Nausea and vomiting are frequently seen in patients following morphine administration.

Pruritus, nausea/vomiting and urinary retention, if associated with continuous infusion therapy, may respond to intravenous administration of a low dose of naloxone (0.2 mg).  The risks of using narcotic antagonists in patients chronically receiving narcotic therapy should be considered.

In general, side effects are amenable to reversal by narcotic antagonists.

NALOXONE INJECTION AND RESUSCITATIVE EQUIPMENT SHOULD BE IMMEDIATELY AVAILABLE FOR ADMINISTRATION IN CASE OF LIFE-THREATENING OR INTOLERABLE SIDE EFFECTS AND WHENEVER ASTRAMORPH/PF THERAPY IS BEING INITIATED.

Drug abuse and dependence

Controlled Substance:

Morphine sulfate is a Schedule II narcotic under the United States Controlled Substance Act (21 U.S.C. 801–886).

Morphine is the most commonly cited prototype for narcotic substances that possess an addiction-forming or addiction-sustaining liability.  A patient may be at risk for developing a dependence to morphine if used improperly or for overly long periods of time. As with all potent opioids which are μ-agonists, tolerance as well as psychological and physical dependence to morphine may develop irrespective of the route of administration (intravenous, intramuscular, intrathecal, epidural or oral). Individuals with a prior history of opioid or other substance abuse or dependence, being more apt to respond to the euphorogenic and reinforcing properties of morphine, would be considered to be at greater risk.

Care must be taken to avert withdrawal in patients who have been maintained on parenteral/oral narcotics when epidural or intrathecal administration is considered. Withdrawal symptoms may occur when morphine is discontinued abruptly or upon administration of a narcotic antagonist.

Dosage and administration

Astramorph/PF is intended for intravenous, epidural or intrathecal administration.

Intravenous Administration:

DOSAGE:

The initial dose of morphine sulfate should be 2 mg to 10 mg/70 kg of body weight.  No information is available regarding the use of Astramorph/PF in patients under the age of 18.

Geriatric Use:

Administer with extreme caution (see PRECAUTIONS).

Epidural Administration:

ASTRAMORPH/PF SHOULD BE ADMINISTERED EPIDURALLY BY OR UNDER THE DIRECTION OF A PHYSICIAN EXPERIENCED IN THE TECHNIQUE OF EPIDURAL ADMINISTRATION AND WHO IS THOROUGHLY FAMILIAR WITH THE LABELING.  IT SHOULD BE ADMINISTERED ONLY IN SETTINGS WHERE ADEQUATE PATIENT MONITORING IS POSSIBLE.  RESUSCITATIVE EQUIPMENT AND A SPECIFIC ANTAGONIST (NALOXONE INJECTION) SHOULD BE IMMEDIATELY AVAILABLE FOR THE MANAGEMENT OF RESPIRATORY DEPRESSION AS WELL AS COMPLICATIONS WHICH MIGHT RESULT FROM INADVERTENT INTRATHECAL OR INTRAVASCULAR INJECTION.  (NOTE: INTRATHECAL DOSAGE IS USUALLY 1/10 THAT OF EPIDURAL DOSAGE.)  PATIENT MONITORING SHOULD BE CONTINUED FOR AT LEAST 24 HOURS AFTER EACH DOSE, SINCE DELAYED RESPIRATORY DEPRESSION MAY OCCUR.

Proper placement of a needle or catheter in the epidural space should be verified before Astramorph/PF is injected. Acceptable techniques for verifying proper placement include: a) aspiration to check for absence of blood or cerebrospinal fluid, or b) administration of 5 mL (3 mL in obstetric patients) of 1.5% PRESERVATIVE-FREE Lidocaine and Epinephrine (1:200,000) Injection and then observe the patient for lack of tachycardia (this indicates that vascular injection has not been made) and lack of sudden onset of segmental anesthesia (this indicates that intrathecal injection has not been made).

EPIDURAL ADULT DOSAGE:

Initial injection of 5 mg in the lumbar region may provide satisfactory pain relief for up to 24 hours.  If adequate pain relief is not achieved within one hour, careful administration of incremental doses of 1 to 2 mg at intervals sufficient to assess effectiveness may be given.  No more than 10 mg/24 hr should be administered.

Thoracic administration has been shown to dramatically increase the incidence of early and late respiratory depression even at doses of 1 to 2 mg.

For continuous infusion an initial dose of 2 to 4 mg/24 hours is recommended.  Further doses of 1 to 2 mg may be given if pain relief is not achieved initially.

Geriatric Use:

Administer with extreme caution (see PRECAUTIONS).

EPIDURAL PEDIATRIC USE:

No information on use in pediatric patients is available (see PRECAUTIONS).

Intrathecal Administration

NOTE: INTRATHECAL DOSAGE IS USUALLY 1/10 THAT OF EPIDURAL DOSAGE.

ASTRAMORPH/PF SHOULD BE ADMINISTERED INTRATHECALLY BY OR UNDER THE DIRECTION OF A PHYSICIAN EXPERIENCED IN THE TECHNIQUE OF INTRATHECAL ADMINISTRATION AND WHO IS THOROUGHLY FAMILIAR WITH THE LABELING. IT SHOULD BE ADMINISTERED ONLY IN SETTINGS WHERE ADEQUATE PATIENT MONITORING IS POSSIBLE. RESUSCITATIVE EQUIPMENT AND A SPECIFIC ANTAGONIST (NALOXONE INJECTION) SHOULD BE IMMEDIATELY AVAILABLE FOR THE MANAGEMENT OF RESPIRATORY DEPRESSION AS WELL AS COMPLICATIONS WHICH MIGHT RESULT FROM INADVERTENT INTRAVASCULAR INJECTION. PATIENT MONITORING SHOULD BE CONTINUED FOR AT LEAST 24 HOURS AFTER EACH DOSE, SINCE DELAYED RESPIRATORY DEPRESSION MAY OCCUR. RESPIRATORY DEPRESSION (BOTH EARLY AND LATE ONSET) HAS OCCURRED MORE FREQUENTLY FOLLOWING INTRATHECAL ADMINISTRATION THAN EPIDURAL ADMINISTRATION.

INTRATHECAL ADULT DOSAGE:

A single injection of 0.2 to 1 mg may provide satisfactory pain relief for up to 24 hours.  (CAUTION: THIS IS ONLY 0.4 TO 2 ML OF THE 5 MG/10 ML AMPULE/VIAL OR 0.2 TO 1 ML OF THE 10 MG/10 ML AMPULE/VIAL OF ASTRAMORPH/PF). DO NOT INJECT INTRATHECALLY MORE THAN 2 ML OF THE 5 MG/10 ML AMPULE/VIAL OR 1 ML OF THE 10 MG/10 ML AMPULE/VIAL.  USE IN THE LUMBAR AREA ONLY IS RECOMMENDED.  Repeated intrathecal injections of Astramorph/PF are not recommended.  A constant intravenous infusion of naloxone, 0.6 mg/hr, for 24 hours after intrathecal injection may be used to reduce the incidence of potential side effects.

Geriatric Use:

Administer with extreme caution (see PRECAUTIONS).

REPEAT DOSAGE:

If pain recurs, alternative routes of administration should be considered, since experience with repeated doses of morphine by the intrathecal route is limited.

INTRATHECAL PEDIATRIC USE:

No information on use in pediatric patients is available (see PRECAUTIONS).

SAFETY AND HANDLING INSTRUCTIONS

Astramorph/PF is supplied in sealed ampules and vials. Accidental dermal
exposure should be treated by the removal of any contaminated clothing and
rinsing the affected area with water.

    Each ampule/vial of Astramorph/PF contains a potent narcotic which has
been associated with abuse and dependence among health care providers.
Due to the limited indications for this product, the risk of overdosage and
the risk of its diversion and abuse, it is recommended that special
measures be taken to control this product within the hospital or clinic.
Astramorph/PF should be subject to rigid accounting, rigorous control of
wastage and restricted access.

    Parenteral drug products should be inspected for particulate matter and
discoloration prior to administration, whenever solution and container
permit. DO NOT USE IF COLOR IS DARKER THAN PALE YELLOW, IF IT IS DISCOLORED IN ANY OTHER WAY OR IF IT CONTAINS A PRECIPITATE. 

For the Consumer

Applies to morphine: oral capsule, oral capsule delayed release, oral capsule extended release, oral capsule extended release 24 hr, oral powder for suspension extended release, oral solution, oral syrup, oral tablet, oral tablet extended release

Other dosage forms:

  • epidural suspension extended release
  • injection injectable, injection solution

Along with its needed effects, morphine (the active ingredient contained in Astramorph PF) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking morphine:

Less common
  • Abdominal or stomach pain
  • blurred vision
  • bulging soft spot on the head of an infant
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in the ability to see colors, especially blue or yellow
  • chest pain or discomfort
  • confusion
  • cough
  • decreased urination
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • headache
  • hives, itching, or skin rash
  • increased sweating
  • loss of appetite
  • nausea or vomiting
  • nervousness
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • severe constipation
  • severe vomiting
  • shakiness in the legs, arms, hands, or feet
  • slow heartbeat
  • sweating or chills
Incidence not known
  • Black, tarry stools
  • cold, clammy skin
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • irregular, fast or slow, or shallow breathing
  • lightheadedness
  • loss of consciousness
  • low blood pressure or pulse
  • painful urination
  • pale or blue lips, fingernails, or skin
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • shakiness and unsteady walk
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual bleeding or bruising
  • very slow heartbeat

Get emergency help immediately if any of the following symptoms of overdose occur while taking morphine:

Symptoms of overdose
  • Constricted, pinpoint, or small pupils (black part of the eye)
  • decreased awareness or responsiveness
  • extreme drowsiness
  • fever
  • increased blood pressure
  • increased thirst
  • lower back or side pain
  • muscle cramps or spasms
  • muscle pain or stiffness
  • no muscle tone or movement
  • severe sleepiness
  • swelling of the face, fingers, or lower legs
  • weight gain

Some side effects of morphine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Cramps
  • difficulty having a bowel movement (stool)
  • drowsiness
  • false or unusual sense of well-being
  • relaxed and calm feeling
  • sleepiness or unusual drowsiness
  • weight loss
Less common
  • Absent, missed, or irregular menstrual periods
  • agitation
  • bad, unusual, or unpleasant (after) taste
  • change in vision
  • depression
  • dry mouth
  • face is warm or hot to touch
  • floating feeling
  • halos around lights
  • heartburn or indigestion
  • loss in sexual ability, desire, drive, or performance
  • muscle stiffness or tightness
  • night blindness
  • overbright appearance of lights
  • problems with muscle control
  • redness of the skin
  • skin rash
  • stomach discomfort or upset
  • trouble sleeping
  • uncontrolled eye movements
Incidence not known
  • Abnormal dreams
  • change in walking and balance
  • change or problem with discharge of semen
  • clumsiness or unsteadiness
  • confusion as to time, place, or person
  • delusions
  • dementia
  • feeling of constant movement of self or surroundings
  • general feeling of discomfort or illness
  • holding false beliefs that cannot be changed by fact
  • problems with memory
  • seeing, hearing, or feeling things that are not there
  • sensation of spinning
  • unusual excitement, nervousness, or restlessness

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